Quality & Regulatory Consultation

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Quality & Regulatory Consultation

BioDevelopment


Our organization is prepared to assist companies in developing validations, labels, procedures and submissions that are required through the ongoing regulatory process.


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Overview

Drug development and manufacturing are highly regulated activities in the US market. The department of Health and Human Services houses the Food and Drug Administration which has the statutory authority to regulate how drugs are manufactured, labeled, distributed and marketed. New drugs use the Investigational New Drug (IND) regulatory pathway for conducting the clinical trials needed to assimilate data regarding the safety and efficacy of the drug. After approval, manufacturers are required to develop and administer quality systems that ensure that the good manufacturing regulations in Title 21 section 200 of the Code of Federal Regulations are followed. Our organization is prepared to assist companies in developing validations, labels, procedures and submissions that are required through the ongoing regulatory process.

Customize

Technical Writing
N/A Standard Operating Procedures Quality Plan Process Validation Plan Equipment Verification Plan Forms, Logs and Records Product Labels

Regulatory Submissions
N/A FDA IND Application FDA BLA Application CLIAA Application

Reviews and Audits
N/A Document Review Data Review Desk Audit Site Audit

Testing
N/A Batch Release Testing Quality Control Testing

COLLECT:

Custom collections from a pool of thousands of healthy donors.

CHARACTERIZE:

Flowcytometry characterization of immune cells.

ISOLATE:

Research or GMP grade positive or negative cell selection procedures.

EXPAND:

Flask or automated expansion services.

FREEZE:

Controlled rate freezing using custom cryo-preservatives.

STORE:

Monitored LN2 vapor phase storage of products and samples.